(117 days)
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process.
This document pertains to a 510(k) premarket notification for a medical device called InQu™. As such, it describes the device's intended use, composition, and claims of substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.
The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if relevant for safety and effectiveness.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not applicable as no specific performance study against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a bone void filler and not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that "Testing has confirmed InQu™ is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine." However, it does not provide details of these tests, including acceptance criteria or study methodologies. The core of this 510(k) is the claim of substantial equivalence to its own prior version (K063359), stating it's "in fact the same product as the unmodified predicate device."
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Section 5.0 510(k) Summary
| Submitter Name: | ISTO Technologies, Inc. |
|---|---|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200St. Louis, Missouri 63132 |
| Contact Person: | Gary GageProgram Director |
| Phone Number: | 314-995-6049 |
| Fax Number: | 314-995-6025 |
| Date Prepared: | May 22, 2007 |
| Device Trade Name: | InQu™ |
| Device Common Name: | Resorbable bone void filler |
| Classification Name: | Filler, bone void, calcium salt compound |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV |
| Predicate Device: | InQu™, ISTO Technologies, Inc., K063359 |
| Statement ofIntended Use: | InQu™ is a resorbable bone void filler intended to fill bony gaps orvoids that are not intrinsic to the stability of the bony structure.InQu™ is intended for use as a bone graft substitute in the skeletalsystem (extremities and pelvis). InQu™ is indicated for use as a bone |
SEP 17 2007system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
Device Description, InQu™ is intended for single patient use only. InQu™ is a sterile, Summary of granular, synthetic bone void filler device composed of poly (D, L-Technological lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced Characteristics, and with bone during the healing process. Testing has confirmed InQu™ Comparison to the is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine. InQu™ is substantially Predicate Device equivalent to the predicate device in terms of material composition and technological characteristics, and is in fact the same product as the unmodified predicate device, InQu™ (FDA cleared, K063359).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 2007
ISTO Technologies, Inc. % Patsy J. Trisler, J.D., Regulatory Consultant 1155 Ollivette Executive Pkwy.- Suite 200 St. Louis, MO 63132
Re: K071428
Trade/Device Name: InQuTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 13, 2007 Received: August 15, 2007
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Patsy J. Trisler
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Barbara Buechner
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K071428
Device Name: InQu™
Indications for Use:
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use are a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Seubene BuehuD
(Division Sign-off) for NXM
Division of General, Restorative, and Neurological Devices
510(k) Number K071428
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.